Actively Recruiting
Quadruple Immunotherapy for Pediatric Patients With Relapsed or Refractory Neuroblastoma
Led by Hong Kong Children's Hospital · Updated on 2025-09-15
29
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hong Kong Children's Hospital
Lead Sponsor
T
The University of Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
This trial studies children with relapsed or refractory neuroblastoma, a type of cancer that has returned or not responded to treatment. Researchers are evaluating the safety and effectiveness of a combination immunotherapy that includes natural killer (NK) cells, anti-GD2 antibodies, cytokines interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF), and the drug spironolactone. Participants receive an intravenous infusion of donor NK cells on day 0, plus anti-GD2 antibody (dinutuximab) given from day -6 to day -2, or alternatively naxitamab on days -5, -3, +1, and +3. IL-2 is administered by subcutaneous injection on alternating days from day -1 through day +9. GM-CSF is injected daily starting on day 0 until neutrophil counts recover. Spironolactone is taken orally three times daily from day -1 until GM-CSF administration ends. During the study, children will be monitored for tumor response within 1 to 2 months and followed for up to 1 year to assess overall survival, progression-free survival, tumor relapse, adverse events, and levels of donor NK cells. Various clinical assessments, laboratory tests, and safety monitoring will be conducted throughout the study period.
CONDITIONS
Brief Title
Quadruple Immunotherapy for Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory neuroblastoma
- Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal, ALT ≤500 IU/L
- Left ventricular shortening fraction ≥25%
- Oxygen saturation ≥92% in room air
- Karnofsky or Lansky performance status score ≥50
- Availability of an appropriate HLA-haploidentical NK-cell donor
You will not qualify if you...
- Pregnant or lactating females
- HIV infection
- Patients for whom conventional treatment is considered more appropriate
- Patients unlikely to benefit, such as those with terminal malignancy and life expectancy less than 1 month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive quadruple immunotherapy including intravenous donor natural killer cells, anti-GD2 antibody (dinutuximab or naxitamab), subcutaneous interleukin-2 on alternate days, daily subcutaneous granulocyte-macrophage colony-stimulating factor until neutrophil recovery, and oral spironolactone three times daily.
Multiple visits during treatment period for infusions and injections
Trial Site Locations
Total: 1 location
1
Hong Kong Children's Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Daniel Cheuk
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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